MAUDE Adverse Event Report: Glaukos Corporation iStent Infinite Trabecular Micro-Bypass System; Aqueous Shunt

Model Number	iS3-KR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: iStent Infinite Trabecular Micro-Bypass System
• Common Device Name: Aqueous Shunt
• Manufacturer (Section D): Glaukos Corporation; 229 avenida fabricante; san clemente CA 92672
• Manufacturer (Section G): Glaukos Corporation; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: brittany massey ; 229 avenida fabricante; san clemente, CA 92672 ; +1(949)367-9600
• MDR Report Key: 50923440
• Report Number: 2032546-2026-00089
• Device Sequence Number: 5393813
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 0100853704002470103302521727093021330252KR0317
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: iS3-KR
• Device Lot Number: 330252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female